The Efficacy of VR and AR on Pruritus

Pruritus Clinical Trial

Official title:

Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289038
• Other study ID #: KA180157
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: February 26, 2022

Study information

• Verified date: February 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.

Description:

In this study, there will be three groups: intervention group 1 with autogenic relaxation (AR), intervention group 2 with virtual reality (VR) game application and control group with routine nursing care and kidney functions narration. The number of volunteers to be included in the study was determined by power analysis. Forty patients with itch symptoms will be included in each group. Preliminary application for all three groups will be performed in the patient group registered to the Dialysis Unit of the Nephrology Department of Hacettepe University and Baskent University Hospital. Socio-Demographic Form, 5-D Itch Scale, Dermatology Life Quality Index, State and Trait Anxiety Scale, Pruritus Behavior and SGO / OR Application Log.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 26, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Receiving hemodialysis treatment for the last 6 months,
• Receiving four hour hemodialysis treatment three times a week,
• 18-65 years of age,
• experiencing pruritus for the last month.
• Not taking any pharmacological / non-pharmacological treatment for pruritus
• No cognitive and psychiatric diagnosis,
• Do not use hearing aids,
• Open to communication and cooperation,
• Using smart mobile phone,
• Without liver disease and dermatological diseases,
• Patients who agree to participate in the study will be included in the study.

Exclusion Criteria:

• Pregnant in the research process,
• Kidney transplantation,
• Experiencing discomfort due to virtual reality glasses,
• Patients who voluntarily leave the trial will be excluded from the follow-up.

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Itch
• Pruritus
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Autogenic Relaxation
Autogenic relaxation
• virtual reality game application
virtual reality game application,
• kidney function narration
kidney function narration

Locations

Country	Name	City	State
Turkey	Nese Altinok Ersoy	Ankara	Eyalet/Yerleske

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-D Itch Scale	The score obtained from information about itching severity, frequency, and its effect on daily life activities.	Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.
Secondary	Dermatology Life Quality Index	The scale gives an information about quality of life	Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
Secondary	State-Trait Anxiety Inventory	The scale gives an information about anxiety	Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.